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914 > Drug Product Development > Flashcards

Drug Product Development Flashcards

1
Q

What is preformulation?

A

Determining the physicochemical properties necessary to formulate the compound

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2
Q

What is formulation?

A

Determining the route and composition of the final dosage form

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3
Q

What is manufacturing?

A

The unit operations that are necessary for final dosage preparation

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4
Q

What are the two things to be concerned about for preformulation?

A

Solubility

Stability

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5
Q

What is solubility?

A

Equilibrium State

Some leave the surface, some attach to surface and a products solubility is reaching the equilibrium between these.

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6
Q

What is solubility usually described as?

A

Maximum amount of solute that can be dissolved per 100g of water. it could also be moles of solute per liter of solution.

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7
Q

How are organics solubility?

A

Low solubility, unless they are salts

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8
Q

What are the 3 states of solubility?

A

Completely soluble
Supersaturated
Very supersaturated (labile)

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9
Q

Which of the 3 states of solubility results in crystallization?

A

supersaturation

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10
Q

What are 2 properties of stability?

A

Physical and Chemical

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11
Q

How does physical stability work?

A

When it transforms to different crystal forms, but the chemical stays in tact. Eg. crystalline to amorphous, hydrates, solvates

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12
Q

What defines chemical stability?

A

Chemical reactions.

Results in degradation of product that must be characterized

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13
Q

Why are solids very stable?

A

The crystal lattice helps to keep molecules from reacting

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14
Q

Is the crystalline form or amorphous form more reactive?

A

Amorphous

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15
Q

Where do reactions start?

A

At crystal defects

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16
Q

What are the 5 crystal defects?

A 
Interstitial atom
Substitution larger atom
Substitution smaller atom
Vacancy
Frenkel-pair
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17
Q

What does the Prout-Tompkins equation describe?

A

Reactivity in solids

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18
Q

Are you more concerned with an initial degradation or later degradation in a product?

A

Initial because later degradation means it was a failed product.

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19
Q

What are 4 reactions that can ruin the stability of your drug?

A

Hydrolysis
Oxidation
Photolysis
Dehydration

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20
Q

What is the IPEC?

A

International Pharmaceutical Excipients Council

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21
Q

What is the IPEC definition of an excipient?

A

Any substance other than the active drug or prodrug which has been appropriately evaluated for safety and is included in a drug delivery system for a specific purpose

22
Q

What does the USP do?

A

Provides test procedures and specifications to find the right excipient

23
Q

What are the 6 types of excipients?

A 
Diluents
Disintegrants
Binders
Lubricants
Glidants
Controlled release
24
Q

What is a diluent?

A

Bulk forming agent
Helps make weight practical for tablet
Helps keep tablet together
Enhances powder flow for manufacturing

25
Q

What are some examples of diluents?

A 
Microcrystalline cellulose
Lactose
Calcium phosphate dibasic dihydrate
Starch
Compressible sugar
26
Q

What is a disintegrant?

A

Breaks up solid dosage form, enhancing dissolution

Works by either water uptake and/or swelling

27
Q

What are some examples of disintegrants?

A

Sodium starch glycolate
Croscarmellose sodium
Crospovidone
Starch

28
Q

What is a binder?

A

Gives tables mechanical strength, creates granules in wet milling
Works by either water uptake and/or swelling

29
Q

What are some examples of a binder?

A

Polyvinylpyrrolidone (PVP)
Starch
Microcrystalline cellulose
Polymers

30
Q

What are lubricants?

A

Prevents adherence of tablet to the die after compaction
Over lubrication can affect the dissolution
Used at levels of 0.5%-2%

31
Q

What are some examples of lubricants?

A

Magnesium stearate
Stearic acid
Lubritab
Talc

32
Q

What are glidants?

A 
Improves powder flow
Stops inter-particle friction
Used at levels <0.2%
Low bulk density
Can have problems with asbestos (with talc)
33
Q

What are some examples of glidants?

A

Fumed silica

Talc

34
Q

What are controlled release/protection?

A

Used to extend the release of drug from a matrix

35
Q

What are some examples of controlled release?

A

HPMC

Xanthan gum

36
Q

What are some examples of protection?

A

Eudragits

Won’t dissolve until it reaches a high pH

37
Q

Where does manufacturing start?

A

Preformulation

38
Q

What are two ways to adjust particle sizes and how do they effect the particle?

A

Milling-decreases

Granulation-increases

39
Q

Why do we adjust the particle size?

A

If the particles are different sizes they will not properly mix

40
Q

What are 4 ways to mill?

A

Cutting
Compreshion
Impact
Attrition

41
Q

What is the definition of milling?

A

Create a stress on particle to cause it to break

42
Q

What are two examples of milling machines?

A

Fitz Mill

CoMill

43
Q

What are two methods of granulation?

A

Wet granulation

Dry granulation

44
Q

What are the two processes of wet granulation?

A

Nucleation

Ball growth

45
Q

What are 4 types of granulation?

A

Coalescence
Breakage
Abrasion transfer
Layering

46
Q

What are two machines used for wet granulation?

A

High speed mixer/granulator

Fluidized-bed granulator

47
Q

What are two methods of dry granulation?

A

Slugging-not as much

Roller compaction

48
Q

What is the name of a machine for roller compaction

A

Roller compactor

49
Q

What press is used for small manufacturing?

A

Tablet press

50
Q

What press is used for large manufacturing?

A

Rotary press

51
Q

What tests are ran after the tablet has been made?

A

Tablet thickness Hardness test

914 (4 decks)

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